BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SR PRO CORONARY IMAGING CATHETER, MODEL 38942

    MDR report key: 2091954 · Received May 18, 2011

    Report

    Report Number
    2939204-2011-00270
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: UPDATED PATIENT SEX, DESCRIBE EVENT OR PROBLEM, DEVICE AVAIL. FOR EVAL AND RETURNED TO MFR. ADD'L MFR. NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND NO ISSUES OR DISCREPANCIES WERE FOUND. NO SIMILAR COMPLAINTS FOR STUCK IN LESION WERE FOUND IN THIS LOT. VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED NO DAMAGE ON THE DISTAL TIP OR GUIDEWIRE EXIT PORT ASSEMBLY. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED. WIND UP, A DESIGN ISSUE, IS A RESULT OF THE IMAGING CORE BEING CONSTRAINED WHICH BREAKS THE SIGNAL PATHWAY LEADING TO THE LOSS OF IMAGE. THE STUCK IN LESION AND LOST IMAGE COMPLAINTS ARE UNRELATED. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) CONTAINS THESE WARNINGS: NEVER ADVANCE OR WITHDRAW THE IMAGING CATHETER WITHOUT FLUOROSCOPIC VISUALIZATION BECAUSE IT MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. A CATHETER THAT IS FORCIBLY ADVANCED MAY CAUSE CATHETER DAMAGE RESULTING IN VESSEL INJURY OR PATIENT COMPLICATIONS. IF RESISTANCE IS MET UPON WITHDRAWAL OF THE CATHETER, VERIFY RESISTANCE USING FLUOROSCOPY, THEN REMOVE THE ENTIRE SYSTEM SIMULTANEOUSLY. A CATHETER THAT IS FORCIBLY REMOVED MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. WHEN ADVANCING THE CATHETER THROUGH A STENTED VESSEL, CATHETERS THAT DO NOT COMPLETELY ENCAPSULATE THE GUIDEWIRE MAY ENGAGE THE STENT BETWEEN THE JUNCTION OF THE CATHETER AND GUIDEWIRE, RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION, AND/OR STENT DISLOCATION. WHEN READVANCING A GUIDEWIRE AFTER DEPLOYMENT OF STENT(S), AT NO TIME SHOULD A CATHETER BE ADVANCED ACROSS A GUIDEWIRE THAT MAY BE PASSING BETWEEN ONE OR MORE STENT STRUTS. A GUIDEWIRE MAY EXIT BETWEEN ONE OR MORE STENT STRUTS WHEN RECROSSING STENT(S). SUBSEQUENT ADVANCEMENT OF THE CATHETER COULD CAUSE ENTANGLEMENT BETWEEN THE CATHETER AND THE STENT(S), RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION AND/OR STENT DISLOCATION. USE CAUTION WHEN REMOVING THE CATHETER FROM A STENTED VESSEL. INADEQUATELY APPOSED STENTS, OVERLAPPING STENTS, AND/OR SMALL STENTED VESSELS WITH DISTAL ANGULATION MAY LEAD TO ENTRAPMENT OF THE CATHETER WITH THE STENT UPON RETRACTION. WHEN RETRACTING THE CATHETER, ENSURE THAT THE SHORT RAIL DISTAL TIP IS PARALLEL TO THE GUIDEWIRE. SEPARATION OR BENDING OF THE GUIDEWIRE MAY RESULT IN KINKING OF THE GUIDEWIRE, DAMAGE TO THE CATHETER DISTAL TIP, AND/OR VESSEL INJURY. THE LOOPED GUIDEWIRE OR DAMAGED TIP MAY CATCH ON THE STENT STRUT RESULTING IN ENTRAPMENT. THE REVIEW OF THE DEVICE LABELING FOUND NO EVIDENCE OR INDICATION THAT THE CATHETER WAS USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE. A PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT WAS ASSIGNED TO THE STUCK IN LESION ISSUE AS TORTUOSITY OF ANATOMY, CALCIFICATION, AND A HIGH PERCENT OF STENOSIS ARE ALL POTENTIAL CAUSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER CROSSED A HEAVILY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WHILE PERFORMING PULLBACK "GOT STUCK" AND LOST IMAGE. FOLLOW-UP ATTEMPTS HAVE BEEN UNSUCCESSFUL IN OBTAINING ANY ADDITIONAL DETAILS AROUND THE METHOD(S) THE PHYSICIAN USED TO RELEASE THE DEVICE FROM BEING "STUCK". IT WAS REPORTED THAT AFTER A FEW ATTEMPTS, IVUS WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH THE PATIENT'S CONDITION REPORTED AS "STABLE".

    Description of Event or Problem · 1

    THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER CROSSED A HEAVILY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND WHILE PERFORMING PULLBACK TO VIEW THE LESION, THE IVUS CATHETER BECAME STUCK AND THE IMAGE WAS LOST. THE PHYSICIAN GENTLY PUSHED, PULLED AND ROTATED THE IVUS CATHETER WHICH WAS SUCCESSFUL IN RELEASING THE IVUS CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THE PATIENT'S CONDITION WAS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS SR PRO CORONARY IMAGING CATHETER, MODEL 38942 CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749389420 14141281

    Patients

    Seq Age Sex Outcome Treatment
    1 Other